WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4

K101597 · Agamatrix · NBW · Oct 18, 2010 · Clinical Chemistry

Device Facts

• Record ID: K101597
• Device Name: WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4
• Applicant: Agamatrix
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 18, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The WaveSense Diabetes Manager application is intended for use as a data management system for the WaveSense-enabled Jazz Blood Glucose Meter. It is designed to assist individuals with diabetes in tracking and managing their blood glucose data.

Device Story

WaveSense Diabetes Manager (WDM) is a digital logbook/diabetes management application for iPhone OS. Inputs: blood glucose readings downloaded automatically from WaveSense-enabled BGM via mini-USB cable; manual entry of insulin and carbohydrate intake. Operation: software processes and stores data to provide a digital logbook for review and analysis. Used in home/professional settings by patients and healthcare providers. Output: visual data logs/analysis of glucose, insulin, and carbs. Clinical impact: supports effective diabetes management programs by facilitating data review and evaluation.

Clinical Evidence

No clinical data; bench testing and design control verification/validation performed.

Technological Characteristics

Software-based data management system; platform: Apple iPhone; connectivity: mini-USB port, WaveSense Direct Connect Cable; interfaces with Jazz Blood Glucose Meter.

Indications for Use

Indicated for individuals with diabetes to track and manage blood glucose data using the WaveSense-enabled Jazz Blood Glucose Meter.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Zero-Click Data Management System (k062434)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k101597

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the WaveSense Diabetes Manager application:

1. The name and 510(k) number of Agamatrix's previously cleared device, Zero-Click Data Management System, cleared under k062434. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.

3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for Upgrading the data management system operating platform to Apple's iPhone to be used alone or with the WaveSense Direct Connect Cable and the WaveSense-enable Jazz Blood Glucose Meter with a mini-USB port.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.